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Randomization inference for stepped-wedge designs with noncompliance with application to a palliative care pragmatic trial

存在不依从时阶梯楔形设计的随机化推断:姑息治疗试验应用

While palliative care is increasingly commonly delivered to hospitalized patients with serious illnesses, few studies have estimated its causal effects. Courtright et al. (2016) adopted a stepped-wedge cluster-randomized design to assess the effect of palliative care on a patient-centered outcome. The randomized intervention was a nudge to administer palliative care but did not guarantee receipt of palliative care, resulting in noncompliance. A subsequent analysis using…

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On Anticipation Effect in Stepped Wedge Cluster Randomized Trials

阶梯楔形整群随机试验中的预期效应

In stepped wedge cluster randomized trials (SW-CRTs), the intervention is rolled out to clusters over multiple periods. A standard approach for analyzing SW-CRTs utilizes the linear mixed model, where the treatment effect is only present after the treatment adoption, under the assumption of no anticipation. This assumption, however, may not always hold in practice because stakeholders, providers, or individuals who are aware of the treatment adoption timing (especially when…

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Time-varying treatment effect models in stepped-wedge cluster-randomized trials with multiple interventions

多干预阶梯楔形整群随机试验中的时变处理效应模型

The traditional model specification of stepped-wedge cluster-randomized trials assumes a homogeneous treatment effect across time while adjusting for fixed-time effects. However, when treatment effects vary over time, the constant effect estimator may be biased. In the general setting of stepped-wedge cluster-randomized trials with multiple interventions, we derive the expected value of the constant effect estimator when the true treatment effects depend on exposure time…

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